Kornimate/medical-research-clean huggingface dataset:
optimal cardiopulmonary bypass and anticoagulation management strategies in obese patients undergoing cardiac surgery

Conditions: Cardiopulmonary Bypass; Obesity

Summary: standard heparin management, based on total body weight, is not well established for obese patients undergoing cardiac surgery with cardiopulmonary bypass (cpb). the purpose of this study is to assess the safety and efficacy of using lean body mass (lbm) to determine pump flow rate and/or heparin dosage in obese patients undergoing cpb.


Eligibility criteria:
inclusion criteria: * obese patients (bmi ≥ 30kg/m2) * planned cardiac surgery * age ≥ 18 years exclusion criteria: * permanent pacemaker * known intolerance to protamine * known or suspected allergy to the used antifibrinolytic agent * refusal to receive blood products * planned off pump coronary artery bypass * planned peri-operative use of desmopressin * known heparin-induced thrombocytopenia * known deficiency in protein c, protein s, antithrombin or homozygous factor v leiden * known congenital bleeding disorders * current endocarditis * planned hypothermic circulatory arrest (\<28c) * two or more cardiac surgery procedures * emergency cardiac surgery procedures (medically required within 24hours of presenting with acute symptoms) * planned cpb priming with red blood cells * any known autoimmune disease * any history of stroke or non-coronary thrombotic disorders including deep venous thrombosis and pulmonary embolism * significant (≥50%) carotid artery stenosis * patient dosed with low molecular weight heparin less than 24h before surgery * females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods * confirmed st elevation myocardial infarction (stemi) within 7 days * pre-operative platelet count \<100,000/microliter * anaemia (hematocrit \<32% for females, \<35%for males) * dosed with clopidogrel or ticagrelor within the last 5 days prior to surgery, or prasugrel within 7 days * dosed with gpiib/iiia receptor blockers (abciximab, tirofiban, eptifibatide) ≤ 24 hours prior to surgery * international ratio (inr) \>1.5 on the day of surgery in patients treated with vitamin k antagonist * liver dysfunction (aspartate aminotransferase (ast) or alanine aminotransferase (alt) increased ≥ 2-fold above the upper limit of local laboratory normal ranges) * renal failure (creatinine ≥ 175 micromol/l or dialysis) * current thromboembolic disease other than myocardial infarct * patients who have pre-donated autologous blood * patient presenting with a resistance to heparin

Keywords: heparin allogeneic blood product transfusions bleeding cardiac surgery obesity
effect of alendronate on bone in people with chronic spinal cord injury (sci) previously treated with teriparatide

Conditions: Spinal Cord Injury; Bone Loss; Osteoporosis

Summary: the purpose of this study is to determine if a year of alendronate treatment will maintain or increase bone mass density (bmd) compared to baseline bmd values in people with chronic spinal cord injury (sci). this study will also investigate 1) if alendronate therapy will increase bone strength in people with chronic sci, 2) the number of participants with adverse events from alendronate, and 3) the effects of alendronate on serum markers of bone metabolism.

this extension study will enroll individuals who have completed treatment in the parent protocol "effect of teriparatide, vibration and the combination on bone mass and bone architecture in chronic spinal cord injury" or in the teriparatide extension protocol. this study will allow those individuals who previously received teriparatide to be treated for a year with alendronate to maintain any bone they may have gained and to possibly increase bone mass further. termination of teriparatide is followed by bone loss if anti-resorptive therapy is not initiated, so this approach is optimal for continued treatment of the current group of participants.

Eligibility criteria:
inclusion criteria: * prior enrollment in protocol "effect of teriparatide, vibration and the combination on bone mass and bone architecture in chronic spinal cord injury", (nct01225055). * 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, for the duration of study participation, and for 90 days following completion of therapy. * ability to understand and the willingness to sign a written informed consent. exclusion criteria: * individual with renal insufficiency (calculated creatinine clearance \< 30 ml/min). * individuals who are not able to sit or stand upright for at least 30 minutes after taking their medication. * individuals with poor dental hygiene. * individuals with esophageal abnormalities. * individuals who are not able to tolerate alendronate treatment. * individuals who will not be able to return for all study visits. * patients may not be receiving any other investigational agents. * other medical conditions that in the opinion of the investigator would preclude the subject from completing the study

Keywords: teriparatide alendronate alendronic acid osteoporosis bone fracture bone loss spinal cord injury bone diseases metabolic bone diseases musculoskeletal diseases spinal cord diseases central nervous system diseases nervous system diseases nervous system wounds and injuries bone density conservation agents physiological effects of drugs pharmacologic actions
outcomes of early versus delayed oral feeding after cesarean section in korle-bu teaching hospital

Conditions: Cesarean Section Complications

Summary: study compares the outcomes of feeding mothers early (4 hours ) after cesarean section compared to delayed feeding (on post operation day 1) in terms of gastrointestinal function and maternal satisfaction with the feeding schedule.

patients who are scheduled to undergo elective cesarean section are randomised to two groups, one group will be allowed to feed 4 hours after cesarean section while the other group will be fed traditionally by feeding on the first post op day. gastrointestinal signs and symptoms will be measured such as post operative ileus, vomiting, nausea, abdminal distension. other parameters to be measured include time to ambulate out of bed after surgery, time to start breastfeeding after surgery. satisfaction with both feeding regimes will be assessed after surgery and the incedence of wound infecion will be compared between the two groups after two weeks durung the post natal review.

Eligibility criteria:
inclusion criteria: uncomplicated elective cesarean sections performed under regional anaesthesia without extensive intra operative bowel adhesions. women who give consent to participate in the study. exclusion criteria: * elective cesarean sections complicated by severe haemorrhage, bowel injury requiring bowel manipulation, repair, resection and anastomosis or colostomy. women who require a cesarean hysterectomy. women who require a post-partum hysterectomy. mothers with severe pre-eclampsia. mothers with sickle cell disease. mothers with pregestational or gestational diabetes. mothers who have been scheduled for cesarean section and require general anaesthesia. women who have had a previous laparotomy other than a cesarean section.

Keywords: post-operative ileus early feeding delayed feeding
focused ultrasound spleen stimulation and inflammation in septic shock

Conditions: Septic Shock; Inflammatory Cytokines; Spleen Neuromodulation; Focused Ultrasound; Critical Care

Summary: this study evaluates the safety and effectiveness of focused ultrasound spleen neuromodulation in patients with septic shock, a life-threatening condition marked by excessive inflammation and organ dysfunction. the primary aim is to determine whether non-invasive, focused ultrasound stimulation of the spleen can reduce levels of circulating inflammatory cytokines in this population. eligibility criteria adults aged 18 years or older diagnosed with septic shock and admitted to the icu within 24 hours expected to require intensive care for at least 72 hours study protocol participants will be randomly assigned to one of two groups: intervention group: will receive standard septic shock care plus twice-daily focused ultrasound stimulation over the spleen for five days using a portable device control group: will receive standard septic shock care alone blood samples will be collected at baseline, day 3, and day 5 to measure inflammatory cytokine levels, such as tnf-α, il-1β, il-6, and il-10. additional assessments include lymphocyte subpopulations, organ function scores, icu length of stay, 28-day mortality, and recording of any adverse events. outcome measures primary: change in levels of inflammatory cytokines on day 3 and day 5 secondary: changes in organ function (sofa score), icu length of stay, 28-day survival, and safety/tolerability of the intervention significance focused ultrasound spleen neuromodulation is a novel, non-invasive procedure that may activate the body's anti-inflammatory pathways. this pilot study will provide preliminary evidence on its potential to regulate inflammation and improve outcomes in patients with septic shock, informing future research and clinical practice.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years, regardless of sex * diagnosed with septic shock according to sepsis-3 criteria: sequential organ failure assessment (sofa) score ≥ 2 and requiring vasopressor support to maintain a mean arterial pressure (map) ≥ 65 mmhg. * admitted to the icu within 24 hours of septic shock diagnosis * expected to require intensive care for at least 72 hours * informed consent obtained from the patient or legal representative exclusion criteria: * known pregnancy or breastfeeding * participation in another interventional clinical trial within 30 days * known immunodeficiency or ongoing immunosuppressive therapy * malignancy with life expectancy \< 6 months * contraindications to focused ultrasound (e.g., splenic trauma, splenectomy, local skin infection) * do-not-resuscitate (dnr) order or expected death within 24 hours * any other condition deemed unsuitable for participation by the investigators

Keywords: septic shock focused ultrasound spleen neuromodulation inflammatory cytokines critical care immune modulation pilot study
screening and intervention of masld in children

Conditions: MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease; Children

Summary: non-alcoholic fatty liver disease (nafld) in children and adolescents has recently been renamed metabolic dysfunction-associated steatotic liver disease (masld). it has become one of the leading chronic liver diseases in children. the prevalence of masld is 6.3% among the general pediatric population and 40.4% among overweight and obese children, with an increasing trend each year. masld increases the risk of various metabolic diseases and can eventually lead to liver fibrosis or hepatocellular carcinoma, contributing to the disease burden. previous work by our project team using machine learning methods has identified that fasting insulin, alanine aminotransferase (alt), and waist-to-height ratio (whtr) have good predictive value in overweight and obese children, with a recommendation that children with a whtr ≥ 0.48 should undergo further screening. however, external validation is still required to improve the effectiveness and cost-efficiency of this screening approach. till now, there are no approved drug treatments for paediatric masld, and lifestyle interventions (such as restricting energy intake and increasing physical activity) are the main therapeutic strategies. however, existing studies face limitations, such as small sample sizes, diverse intervention methods, lack of standardization, and short intervention durations, which hinder their clinical application. therefore, it is essential to explore effective health lifestyle intervention models tailored to children. this study aims to: first, optimizing the screening and treatment pathway, assess the cost-effectiveness and applicability of whtr as a screening tool, and develop a tiered screening system suitable for chinese children; second, integrating school, clinic, family, and community resources to establish a multifacted lifestyle intervention model and evaluate its efficacy.


Eligibility criteria:
inclusion criteria: * parents agree and support their children's weight loss, and students and parents have informed consent; * students in two to four grade aged 7 and 11 years old; * students with whtr \> 0.48. exclusion criteria: * medical history of heart disease, hypertension, diabetes, tuberculosis, asthma, virus hepatitis or nephritis; * obesity caused by endocrine diseases or side effects of drugs; * abnormal physical development like dwarfism or gigantism; * physical deformity such as severe scoliosis, pectus carinatum, limp, obvious o-leg or x-leg; * inability to participate in school sport activities; * a loss in weight by vomiting or taking drugs during the past 3 months.

Keywords: children masld lifestyle intervention screening
a study of retrovir and epivir alone or in combination with 141w94 in hiv-infected patients

Conditions: HIV Infections

Summary: the purpose of this study is to see if it is safe and effective to add 141w94 to an anti-hiv regimen that includes retrovir plus epivir.

this is a double-blind, placebo-controlled, two-arm study comparing treatment with a triple regimen consisting of 141w94, retrovir, and epivir and a double regimen consisting of retrovir and epivir.

Eligibility criteria:
inclusion criteria patients must have: * hiv-positive status. * screening viral load \>= 10,000 copies/mm3 14 days prior to entry. * cd4+ cell counts \>= 200 cells/mm3 14 days prior to entry. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: clinical diagnosis of aids (cdc 1993 classification c). concurrent medication: excluded: terfenadine, astemizole, cisapride, triazolam, medazolam, and ergotamine/dihydroergotamine-containing regimens. patients with the following prior conditions are excluded: clinically relevant hepatitis in the previous 6 months. prior medication: excluded: * greater than 4 weeks of any nucleoside antiretroviral therapy. * previous therapy with an hiv protease inhibitor. * cytotoxic chemotherapeutic agents within 4 weeks prior to entry. * immunomodulating agents within 3 months prior to entry. prior treatment: excluded: radiotherapy within 4 weeks prior to entry. risk behavior: excluded: current alcohol or illicit drug use that may interfere with the patient's ability to comply with the dosing schedule or protocol evaluations.

Keywords: drug therapy, combination zidovudine hiv protease inhibitors lamivudine vx 478 reverse transcriptase inhibitors anti-hiv agents viral load
the supporting patient activation in transition to home intervention

Conditions: Medication Adherence; Self-care; Heart Failure; Chronic Obstructive Pulmonary Disease

Summary: this study evaluates if motivational interviewing sessions aiming to motivate recently discharged patients with either chronic obstructive pulmonary disease or congestive heart failure to be active in post-discharge self-management can reduce re-hospitalization rates.

included patients transition to home will be bridged through a telephone-call from a patient activation coach two days post-discharge. the patients will thereafter get motivational interviewing sessions by the same patient activation coach with the the goal that the patients are motivated to the knowledge, skills and confidence needed to manage the four main activity areas: 1) medication management; 2) adhere to care plan/ follow-up visits according to the discharge plan; 3) recognize indications (symptoms/signs) that the condition is worsening and how to respond; and 4) contact and manage relations/encounters with health care providers. patients in control group will receive standard care, i.e. discharge and follow-up as in normal procedures. the investigators will use a randomization in permuted blocks of 10 intervention patients and 10 control patients included. to test the hypothesis that the re-hospitalizations rate is 15 % lower in the intervention group compared to the control group 242 patients (121 per group) are needed for power of 80% with the level of significance set to 5 % using two-sided chi-square.

Eligibility criteria:
inclusion criteria: * patients aged 18 years or older with chronic obstructive pulmonary disease or congestive heart failure admitted at a short-term medical ward and who are living in their private home. exclusion criteria: * diagnoses of dementia or cognitive impairment, and need of interpreter to participate in conversations. the exclusion criteria are related to the patients' possibilities to participate in the motivational interviewing sessions by phone.

Keywords: patient participation empowerment medication management symptom management self determination theory motivational interviewing
smart design to compare antipsychotic treatments in treatment-resistant schizophrenia

Conditions: Treatment-resistant Schizophrenia

Summary: the project intends to take treatment-resistant schizophrenia as the research object and uses sequential multiple assignment randomized trial(smart) design to define the treatment recommendations of different drug regimen for treatment resistant schizophrenia and to determine the physical enhancement regimen for clozapine-resistant schizophrenia and to explore targeted regulation scheme for ultra-resistant schizophrenia.

this trial is a sequential multiple-assignment rct design of antipsychotic drugs, planning to recruit 162 people with treatment-resistant schizophrenia followed for 12 months. the study includes three treatment phases and a naturalistic follow-up phase. participants who meet the response criteria remain on that treatment for the duration of 12-month treatment. if the participants fail the treatment or can't tolerant the side effects, the patient moves to the next phase of the study to receive a new treatment.

Eligibility criteria:
inclusion criteria: 1. meet the dsm-5 diagnostic criteria for schizophrenia, 2. be 18-55 years of age, 3. treatment-resistant schizophrenia:no response to sufficient doses (400-600 mg/ day cpz equivalent) of at least two antipsychotics in the past 5 years, 4. informed consent. exclusion criteria: 1. patients with medical or psychiatric comorbidities and those who require concomitant other medications are excluded. 2. patients with contraindications to even one of the proposed treatment arms are excluded. 3. patients with risks such as extreme agitation, stupor or suicide are excluded. 4. female patients with pregnancy or breast-feeding are also excluded.

Keywords: schizophrenia treatment-resistant antipsychotics combination
inhaled corticosteroid withdrawal in patients with chronic obstructive pulmonary disease

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: this is a randomised study to be conducted in patients with severe to very severe chronic obstructive pulmonary disease (copd) to establish whether there is a need for these patients to be continuously treated with an inhaled corticosteroid on top of two potent long-acting bronchodilators. the study also aims to identify the type of patients who are likely to benefit from inhaled corticosteroid maintenance therapy.


Eligibility criteria:
inclusion criteria: 1. male or female aged 40 years or more 2. severe to very severe chronic obstructive pulmonary disease (copd) 3. current or ex-smoker with smoking history of at least 10 pack years 4. at least one documented exacerbation of copd in previous year exclusion criteria: 1. significant diseases other than copd; significant alcohol or drug abuse 2. current clinical diagnosis of asthma requiring steroid treatment 3. history of thoracotomy with pulmonary resection 4. regular use of daytime oxygen 5. recent history (within 3 months) of myocardial infarction 6. recent (within 6 weeks) respiratory infection or copd exacerbation 7. recent (within 6 weeks) treatment with systemic corticosteroids at doses in excess of 5milligram / day 8. recent (within 3 months) unstable or life-threatening cardiac arrhythmia requiring intervention 9. recent (within 1 year) hospitalisation for cardiac failure 10. malignancy requiring chemotherapy or radiotherapy 11. clinical diagnosis of bronchiectasis 12. pregnant or nursing women 13. known hypersensitivity to study drugs 14. current or recent (within 30 days) participation in another clinical study 15. current participation in or recent completion (within 4 weeks) of a pulmonary rehabilitation program
management of coagulopathy during orthotopic liver transplantation. comparison between rotem-based management and standard biological assessment.

Conditions: Liver Transplantation

Summary: in current practice, management of coagulation during liver transplantation is performed either through standard coagulation status or with rotem® depending on practitioner choice and availability of materials. in this context, the rotem® is used since over 2 years by anesthesiologists in the digestive surgery department of the croix rousse hospital in lyon, france. indeed liver transplantation surgery is at high risk of bleeding due to coagulopathy developed by patients who are eligible, due to coagulation factor synthesis deficiencies in the cirrhotic liver. on the other hand the standard coagulation profile is a poor reflection of coagulopathy in such patients because the imbalance between pro- and anti-coagulant factors are not taken into account by pt and aptt measures. management of intraoperative hemorrhage may be facilitated by the rotem® which is performed from whole blood and which allows the detection of abnormalities in the balance between pro- and anti-coagulant factors. this technique was already evaluated in liver, cardiac, and obstetric surgery but also in traumatology. randomized trials in liver transplantation surgery have shown changes in transfusion practices but did not focus on the consequences of such changes.


Eligibility criteria:
inclusion criteria: * patients \>=18 years of age * patients undergoing orthotopic liver transplantation in the croix-rousse hospital within 24 months after inclusion and who have received clear information and who are not opposed to the participation in the study * patients affiliated to a social security system or similar * patients not subject to a measure of legal protection exclusion criteria: * opposition to participation in the study * patients \<18 years of age * patients who participated in the previous month to another study protocol * pregnant women or breast-feeding * not affiliated to a social security system * patients with hemostasis pathology (hemophilia, ...)

Keywords: cirrhosis, transplantation, transfusion, rotem®