Kornimate/medical-research-clean huggingface dataset:
sirolimus associated with tacrolimus at low doses in elderly kidney transplant patients

Conditions: Disorder Related to Renal Transplantation; Cytomegalovirus Infections

Summary: there is no consensus on the best immunosuppressive regimen in elderly people. the aim of this study will be to evaluate the efficacy of sirolimus associated with tacrolimus in elderly kidney transplant recipients. the investigators will conduct a single-center prospective randomized study comparing the combination of tacrolimus with sirolimus at reduced dose rate (tacrolimus + sirolimus group) against tacrolimus with mycophenolate (tacrolimus + mycophenolate group). the investigators will include all kidney transplant patients over 60 years of age. the investigators will evaluate estimated glomerular filtration rate and incidence of cytomegalovirus in 12 month follow-up.

study design this will be a single-center, prospective, 12-month randomized controlled trial aiming to compare sirolimus associated with tacrolimus in elderly renal transplant patients as to safety and incidence of cytomegalovirus (cmv) infection. treatments in the control group (tacrolimus + mycophenolate) the investigators will use tacrolimus (starting with 0.1 mg/kg twice daily adjusted to target serum levels by 4-8ng/ml at the third month and then 3-7ng/ml from the third month to the 12th month) and mycophenolate sodium 720 mg twice daily. a dose reduction of mycophenolate sodium to 720 mg/day will be accepted due to possible side effects of the drug. in the treatment group (tacrolimus + sirolimus) the investigators will use tacrolimus (starting with 0.1 mg/kg twice daily adjusted to target serum levels by 4-8 ng/ml at the third month and then 3-7 ng/ml from the third month to the 12th month) and sirolimus 2 mg/day (adjusted serum levels at 4-8 ng/ml throughout the study period). in all groups, patients will receive prednisone 30 mg/day (in the first month with weekly reductions up to 5 mg/day at the end of the second month). induction therapy consisted of basiliximab or antithymocyte globulin (thymoglobulin, genzyme®). thymoglobulin will be used in patients with panel reactivity class i greater than 50 % (at a dose of 1mg/kg for 5 days).

Eligibility criteria:
inclusion criteria: 1. patients aged more than 60 years and recipients of compatible renal transplant exclusion criteria: 1. receptors of multiple organs; 2. non-heart beating donors; 3. donors aged under 5 or over 65 years; 4. patients with body mass index greater than 35

Keywords: kidney transplantation sirolimus cytomegalovirus aged
escalation of plerixafor for mobilization of cd34+ hematopoietic progenitor cells and evaluation of globin gene transfer in patients with sickle cell disease

Conditions: Sickle Cell Disease

Summary: the purpose of this research study is to test the safety and efficacy of a drug called plerixafor. plerixafor is approved by the us fda for use in increasing blood stem cell counts before collection in cancer patients. it is not yet approved for patients with sickle cell disease. the investigators want to find out if plerixafor can be used to increase cell counts in patients with sickle cell disease.


Eligibility criteria:
inclusion criteria: * patients must have confirmed and measurable sickle cell disease, defined by ss or sβ thalassemia confirmed by hemoglobin fractionation. * ≥ 18 to 65 years of age * patient must have a ecog performance status ≤2 or karnofsky score \> 70% * patients must have acceptable organ and marrow function as defined below: * wbc ≥ 3,000/μl * anc ≥ 1,500/μl * platelets ≥150,000//μl * hemoglobin ≥ 6 gm/dl * calculated creatinine clearance ≥ 60ml/min \* \*using the cockcroft-gault equation \[140 - age(yrs)\] \[weight(kg)\] x 0.85 if female 72 \[serum creatinine (mg/dl\] * women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. * each patient must be willing to participate as a research subject and must sign an informed consent form. exclusion criteria: * patients who are: * receiving or received treatment with an investigational agent within 4 weeks prior to entering the study or * have not recovered from adverse events due to agents administered more than 4 weeks earlier as determined by the treating physician. * patients with alt(sgpt) \> 2.5 x upper limit of normal * patients with a creatinine clearance of \< 60 ml/min * patients who have uncontrolled illness including, but not limited to: * ongoing or active infection * emergency room admission or hospitalization in the past 14 days * major surgery in the past 30 days * medical/psychiatric illness/social situations that would limit compliance with study requirements as determined by the treating physician. * female patients who are pregnant or breast-feeding * patients with active hepatitis b, hepatitis c, or hiv infection * patients with poor cardiac function as defined by an ejection fraction \< 40% are excluded due to potential poor tolerance of the fluid shifts with leukapheresis (only for patients enrolled on second phase of protocol for leukapheresis).

Keywords: plerixafor 13-229
modified intermittent fasting in psoriasis

Conditions: Psoriasis Vulgaris; Psoriasis

Summary: the complexity of psoriasis is partially affected by dietary effects, and some diets have shown to be beneficial in psoriasis. intermittent fasting has been shown to improve many of these disturbances, even inflammatory parameters such as tnf and crp. individuals with psoriasis have been reported to have impaired intestinal integrity and it has been suggested that gut health affects skin health, pointing towards a gut-skin axis. understanding how dietary lifestyles can affect epithelial lineages such as the skin and gut, will greatly improve our understanding on the development of psoriasis. modified intermittent fasting (mif) of 2 non-consecutive days has shown to have positive metabolic effects, yet its effect on gut and skin remains underexplored.

to study the role of gut health, more specifically the intestinal barrier, in individuals with psoriasis and the effects of fasting on both organs in a prospective cohort cross-over study. the investigators will test whether mif can improve (i) skin lesions (clinical and molecular level), (ii) intestinal integrity markers such as zonulin, ifabp and scd14, and (iii) the timing of these improvements. as such, it can be determined whether fasting benefits psoriasis and gut health. mif will consist of a limited calorie uptake of 500 kcal for 2 days a week. the remaining days of the week are as usual. gut and skin health will be tested at the molecular level during 12 weeks with another crossover of 12 weeks (alternating between mif and usual diet).

Eligibility criteria:
inclusion criteria: * mild psoriasis (pasi \< 10) * at least bmi of 20 * stable weight for last 3 months * topical treatment * availability of smartphone and willing to install app * willing to attend dematology clinic at ghent university hospital exclusion criteria: * underweight and/or following strict diet * use of anti, pre and/or probiotics (last 3 months) * use of immunosuppressants (last 3 months) * smoking * consumption of fish oil * diagnosed diabetes (type ½) * excessive physical activity * pregnancy or breastfeeding * more than 14 alcohol units/week * history of cardiac condition(s)

Keywords: psoriasis fasting modified intermittent fasting leaky gut intestinal barrier
analgesic efficacy of erector spinae plane block after breast cancer surgery

Conditions: Postoperative Pain; Breast Cancer

Summary: erector spinae plane block(espb), which is firstly used for thoracic neuropathic pain, is newly developed and highly promising fascial plane block for providing postoperative analgesia for a great deal of surgeries including breast surgery. the investigators aim to study efficacy of espb for patients who undergone breast cancer surgery and is expected to benefit from opioid-sparing effect of this technique.

this is a retrospective, single-center clinical trial to evaluate analgesic efficacy of erector spinae plane block (espb) after breast cancer surgery. participant's demographics and medical history, type and extent of surgery, systemic opioid and non-opioid analgesic consumptions, hemodynamic variables and adverse events during and first 24 hours after surgery. after operation, pain scores at first 24 hours, 1., 3., and 6. month will be obtanied from surgical ward and pain clinic registires. patient controlled analgesia device usage history will be obtained from device database at our clinic.

Eligibility criteria:
inclusion criteria: * asa i-ii patients undergoing breast surgery for breast cancer * becoming available of complete records about study data exclusion criteria: * asa iii-iv patients * missing records about study data

Keywords: erector spinae plane block breast cancer surgery postoperative pain analgesic
impact of nutritional status on clinical outcome in picu

Conditions: Nutritional Disorder

Summary: malnutrition is believed to be associated with clinical outcomes in ill patients and several studies have shown that nutrition status play a major role in disease prognosis in adults . different authors have described an increase in morbidity and mortality attributable to malnutrition, as it lead to state of partial immunosuppression, delay wound healing ,causes muscular atrophy and increase length of stay.

several studies have investigated the predictive role of an extremely low body weight on disease prognosis and outcomes among general and critically ill children .they enrolled all patients consecutively admitted to pediatric intensive care unit picu) , therefore , being underweight may have resulted from endocrine diseases, genetic syndromes or other systemic underlying illnesses . the impact of low body weight on outcomes of acutely critically ill but previously healthy children is still unknown. many studies evaluate the clinical status and outcome by pediatric index of mortality (pim2) as a popular and reliable predictive score . in this study, we will investigate the impact of being underweight or proper weight on mortality and morbidity among acute critically ill children with no genetic, endocrine, or chronic systemic illness at picu admission

Eligibility criteria:
inclusion criteria: 1. all children admitted to picu with nutritional disorders 2. children with acute diseases and anthropometric measurements taken within first 24hours exclusion criteria: 1-children with underlying chronic diseases (eg cerebral palsy ,type 1 or 2 diabetes , epilepsy, metabolic diseases, inflammatory bowel disease , liver cirrhosis , immunodeficiency , autoimmune disordes , malignancy , chronic kidney disease) and postoperative patients.
research on early diagnosis and clinical transformation of nuclide probe based on bioorthogonal-gastric cancer mucin target visualization

Conditions: Solid Tumor

Summary: the symptoms of early gastric cancer are extremely insidious and most patients are identified as advanced at the time of initial diagnosis. starting from the clinical needs, this project selects solid tumors and pathogenic glycoprotein synthesis of key glycopeptide antigen determinant mucin (muc) family of multiple molecules as the research object. based on the digestive system tumor research cohort established in the early stage, this project intends to verify the tumor microenvironment characteristics of the muc family and gastric cancer treatment resistance through immunohistochemistry, cosmc gene sequencing and other technologies, and screen key muc family proteins. based on the discovery of differential recognition of cosmc deficient cells by antibodies, muc1-targeted specific monoclonal antibody was developed. further development of spatial mucinomics based on laser ablation inductively coupled plasma mass spectrometry (la-ipc-ms) and spatial metabolome based on desorption electrospray mass spectrometry (desi-ms) to analyze the structure and immunosuppressive mechanism of key gastric cancer glycoprotein muc. after obtaining key targeted antibodies, with the help of biological orthogonal and click chemistry technology, the original clinical translational research based on mucin targeting was carried out, and a high-affinity nuclide conjugate drug (rdc) with "triple binding" of gastric cancer mucin was constructed and clinical translational research was carried out, which provided new ideas for the accurate diagnosis and treatment of gastric cancer in the early stage.


Eligibility criteria:
inclusion criteria: 1. aged ≥18 years old; ecog 0 or 1; 2. patients with solid tumor confirmed by histopathology; 3. patients with imaging confirmed measurable lesions; 4. life expectancy \>=12 weeks. exclusion criteria: 1. significant hepatic or renal dysfunction; 2. ls pregnant or ready to pregnant; 3. cannot keep their states for half an hour; 4. refusal to join the clinical study; 5. suffering from claustrophobia or other mental diseases； 6. any other situation that researchers think it is not suitable to participate in the experiment.
neuromuscular-blocking agents and hypoxemia during intubation in infants (roc-hypox)

Conditions: Hypoxemia

Summary: the prevention of the occurrence of respiratory events is a constant concern in pediatric anesthesia, as these represent the main cause of the anesthesic mortality. these events occur partly during induction of anesthesia and are all the more frequent as the child is young. the french recommendations do not propose the use of neuromuscular-blocking agents in pediatric anesthesia. this recommendation is controversial in a recently published study, it has been shown that the use of neuromuscular blocking agents during induction in children under 2 years improves intubating conditions and reduces the incidence of hemodynamic and respiratory events. this monocentric study, centered on intubating conditions, does not allow to conclude on the influence of muscle relaxants on reduction of the respiratory morbidity. the objective of study is to demonstrate that, in children under 2 years, changing the anesthesia protocol can reduce the incidence and severity of episodes of hypoxemia associated with respiratory events occurring during induction


Eligibility criteria:
inclusion criteria: * age \<2 years * indication of general anesthesia with tracheal intubation * inhalational induction scheduled * written informed consent of both parents exclusion criteria: * contra-indication to inhalational induction (full stomach) * contra-indication to the use of rocuronium * american society of anesthesiologists score (asa) iii or iv * intracranial surgery * parental refusal * absence of affiliation to social security
study of cancer peptides vaccine plus gm-csf as adjuvant treatment for high risk (txn2-3m0) or metastatic breast cancer with no evidence of disease

Conditions: Breast Cancer

Summary: this study will evaluate the safety and feasibility of administering a peptide vaccine consisting of twelve different tumor-rejection antigens to patients with high risk (txn2-3m0) or metastatic breast cancer with no evidence of disease following their completion of systemic therapy. the vaccine is designed to elicit immune responses against twelve different pathways that are essential to tumor growth, survival and metastasis.

the primary endpoint will be to determine the safety and feasibility of administering cancer peptides to patients with high risk (txn2-3m0) or metastatic breast cancer with no evidence of disease following their completion of systemic therapy, with the secondary objectives of evaluating immune response disease relapse survival. two cohorts of 9 patients each will be treated with different doses of the vaccine. they will receive the peptide vaccine subcutaneously on weeks 0,1,2,4,5, and 6 and then receive the immunizations every 1 month for 6 months or disease recurrence. toxicity will be assessed at each dose level using ctcv3 toxicity criteria.

Eligibility criteria:
inclusion criteria: * hla-a2 patients with histologically confirmed, txn2-3m0 or metastatic breast cancer with no evidence of disease who have completed their adjuvant systemic chemotherapy or trastuzumab * subjects will not be treated until 4 or more weeks after any prior chemotherapy, radiation therapy or immunotherapy, but they may be receiving hormonal therapy exclusion criteria: * history of autoimmune disease * serious intercurrent chronic or acute illness * active hepatitis * serologic evidence for hiv, splenectomy * receiving steroid or immunosuppressive therapy

Keywords: immunotherapeutic vaccine breast cancer txn2-3m0 breast cancer metastatic breast cancer immunotherapy antigen histologically confirmed, txn2-3m0 or metastatic breast cancer
effects of osteopathic treatment on pulmonary function after coronary artery bypass graft surgery

Conditions: Mechanical Complication of Coronary Artery Bypass Graft; Respiratory Depression; Pain; Quality of Life

Summary: the purpose of this study is to determine the short and long term effects of osteopathic treatment on pulmonary function, pain and quality of life in patients after coronary artery bypass graft (cabg) surgery. the study is a randomized controlled trial.

coronary artery bypass graft (cabg) surgery is performed worldwide. several studies have found that there is a decrease in pulmonary function, loss of thoracic mobility and a high prevalence of chronic poststernotomy pain (cpsp) after cabg. so far there is no effective treatment for these conditions. the ostincare study aims to investigate whether osteopathic treatment has an added value in the treatment of these patients.

Eligibility criteria:
inclusion criteria: * planned coronary artery bypass graft (cabg) surgery at the jessa hospital hasselt * planned endoscopic atraumatic coronary artery bypass (endo acab) surgery at the jessa hospital * planned minimal invasive aortic valve replacement (mini avr) surgery at the jessa hospital exclusion criteria: * thoracic surgery in the past * redo cabg * complications after cabg, requiring long-term (more than 6 days) admission to intensive care * pathologies of the lungs * pathologies of the heart, other than the coronary artery disease * surgery in the sub diaphragmatic region: epigastric region, left and right hypochondriac region.

Keywords: coronary artery bypass graft osteopathic medicine vital capacity quality of life cardiac rehabilitation
study on the incidence of intussusception (is) in children aged < 12 months in japan

Conditions: Intussusception

Summary: this study aims to analyse baseline data on is in order to monitor the possibility of increased risk of is in children aged \<12 months after introduction of the rotarix vaccination in japan.


Eligibility criteria:
inclusion criteria: * a male or female infant aged \< 12 months at the time of is diagnosis and affiliated to the jmdc-mdb database. * an is case should be identified as per the icd-10 diagnostic code-k56.1 (any-field listed), examination codes, and procedural codes. exclusion criteria: not applicable

Keywords: japan retrospective observational epidemiological study children aged < 12 months intussusception
apapitatin combined with sox for palliative adjuvant chemotherapy in patients with advanced gallbladder carcinoma

Conditions: Gallbladder Carcinoma

Summary: a single-center open, randomized, controlled study to compare the apapitatin mesylate combined with sox regimen and sox regimen for palliative adjuvant chemotherapy in patients with advanced gallbladder carcinoma

the aim of the study is to observe and evaluate the progression-free survival time (pfs), overall survival time (os) and safety of patients with advanced gallbladder carcinoma treated with apatinib mesylate combined with sox

Eligibility criteria:
inclusion criteria: 1. ages 18 to 75 2. uicc/ajcc gallbladder tnm staging (the eighth edition), ⅲ b - ⅳb (excluding m1) postoperative pathological diagnosis of gallbladder carcinoma;patients confirmed to have undergone r1/r2 cholecystectomy or palliative surgery; 3. the primary treatment is surgical resection or potentially resectable cholecystic carcinoma without other treatment 4. ecog performance status ≤1 5. the liver and kidney function meets the following conditions： bil\ 50ml/min（cockcroft-gault）; 6. other test rooms meet the following requirements: hemoglobin ≥ 90 g/l (no blood transfusion within 14 days)；neutrophilic granulocyte count \> 1.5x109 /l;the platelet count ≥ 80 x 10 \^ 9/l; 7. estimated life expectancy \> 3 months. 8. before the enrollment, the heart function is good. there is no episode of myocardial infarction within half a year. for example, if you have hypertension or coronary heart disease, you should ensure that it is within the controllable range. 9. patient able and willing to provide written informed consent and to comply with the study protocol and good compliance, with follow-up. exclusion criteria: 1. non gallbladder carcinoma 2. significant clinical bleeding symptoms or a clear tendency to bleed occurred within the first month of randomization, such as cough/hemoptysis of 2.5ml or more, gastrointestinal bleeding, esophagogastric varices at risk of bleeding, hemorrhagic gastric ulcer, etc. 3. other topical treatments during the study (including intraperitoneal chemotherapy, radiotherapy, etc.) 4. pregnant or lactating women； 5. those who suffer from high blood pressure and cannot be treated to the normal range by antihypertensive drugs； 6. hiv infection or the presence of aids-related diseases, or severe acute and chronic diseases; 7. have grade ii or higher myocardial ischemia or myocardial infarction、poorly controlled arrhythmia； 8. severe active infections； 9. there are secondary malignant tumors or other tumors within 3 years before the start of the study and there is metastasis of the brain or meninges. 10. researchers believe that their compliance is poor 11. there are contraindications for apatinib and s-1
evaluation of effect of trc101 on progression of chronic kidney disease in subjects with metabolic acidosis

Conditions: Metabolic Acidosis; Chronic Kidney Disease

Summary: the purpose of this study is to evaluate the effect of trc101 on the progression of chronic kidney disease (ckd) and to evaluate the safety profile of trc101 in ckd patients with metabolic acidosis.

this is a randomized, double-blind, placebo-controlled trial. eligible subjects will be randomized in a 1:1 ratio to trc101 or placebo. the primary endpoint of the study will be progression of renal disease, defined by time to first occurrence of any event in the composite endpoint consisting of a confirmed ≥ 40% reduction in egfr, end-stage renal disease (esrd), and renal death. the study will terminate when the independent blinded clinical endpoint adjudication committee has positively adjudicated the targeted number of primary efficacy endpoint events. the maximum duration of follow-up for a randomized subject is anticipated to be approximately 6 years.

Eligibility criteria:
inclusion criteria: * estimated glomerular filtration rate (egfr) 20 - 40 ml/min/1.73m\^2. * serum bicarbonate 12 - 20 meq/l. * on maximum tolerated dose of ace inhibitor and/or arb. exclusion criteria: * acute metabolic acidosis. * anticipated dialysis or kidney transplant within 6 months. * recent acute kidney injury.

Keywords: serum bicarbonate renal outcomes trc101 egfr veverimer