Kornimate/medical-research-clean huggingface dataset:
assessment of the cerebral perfusion during the period of deep hypothermia at 18°c in patient undergoing pulmonary endarterectomy surgery.

Conditions: Hypothermia; Cerebral Perfusion; Transcranial Doppler Ultrasound; Pulmonary Hypertension

Summary: cardiopulmonary bypass (cpb) surgery present risk of acute postoperative neurological complications. these complications are most often postoperative cognitive dysfunction (confusion, cognitive disorders, executive disorders) with a prevalence of up to 40% at 5 years, and ischemic (stroke) with an incidence of between 0.4 and 14%. the causes are usually multifactorial, but altered cerebral perfusion during cpb surgery is an important prognostic factor. data regarding the effect of deep hypothermia on cerebral perfusion during cpb in adult are scarce. currently, aortic arch replacement following aortic dissection or aneurysm, and pulmonary artery endarterectomy (pae) in the treatment of pulmonary hypertension of post embolic origin are performed under deep hypothermia. in this latter indication, the need to obtain a completely bloodless operating field necessitates complete circulatory arrest during short period of time to enable the surgeon to optimally remove the clot materials located into the pulmonary arteries. to protect the brain and avoid irreversible brain injury during circulatory arrest(s), body temperature is lowered at 18-20°c. deep hypothermia can lead to significant arterial vasoconstriction, which can reduce the blood supply to the brai. it also increases the solubility of co2 in the blood, leading to respiratory alkalosis, which can also lead to vasoconstriction of cerebral vessels, increasing the risk of ischemic lesions. in adult there is no consistent data on the cerebral perfusion during pae surgery under deep hypothermia at 18-20°c. animal studies showed that cerebral regulation seems to be preserved under these conditions. a better understanding of the effect of deep hypothermia on cerebral perfusion during pae surgery is essential to adapt our management to limit the occurrence of postoperative neurological complications.


Eligibility criteria:
inclusion criteria: * scheduled for pulmonary artery thromboendarterectomy surgery. * patient with free, written and informed consent. * patient affiliated to a social security scheme (beneficiary or beneficiary's beneficiary). * french-speaking patient. exclusion criteria: * patient refusing to participate in the study. * patient under guardianship. * patient deprived of liberty. * pregnant or breast-feeding women.

Keywords: pulmonary endarterectomy cerebral perfusion hypothermia transcranial doppler ultrasound cardiopulmonary bypass
treatment with lactobacillus rhamnosus and lactobacillus acidophilus for patients with active colonic crohn's disease.

Conditions: Crohn's Disease

Summary: the purpose of this study is to determine whether a probiotic containing lactobacillus acidophilus and lactobacillus rhamnosus is effective as treatment for patients with active colonic crohn's disease

the aetiology of crohn's disease is still not known. in the recent years there has been an increasing interest in the relationship between the gastrointestinal flora and gut function. several studies have shown promising results for the use of probiotics in patient with inflammatory bowel disease. aim: the aim of the current study is to evaluate the effect of a probiotic suspension in patients with active colonic crohn's disease. methods: the study is a two-centre, randomised placebo-controlled, and double-blind trial. patients above the age of 18 years, attending our out-patient clinic, can be included if they have crohn's disease in the colon or colon and small bowel and have active disease with a cdai: 220-400. patients are not included if they have undergone larger bowel resections, have been treated with antibiotics within the last two months, if dose of prednisolone has been changed within the last 4 weeks, or dose of immunosuppressives has been changed within the last 2 months. during the study period no changes in medication is allowed. during an 8 week period patients are treated with a combination of lactobacillus rhamnosus strain 19070-2 and lactobacillus acidophilus strain 18911-2 (10ee9 colony forming unit/ml). freeze-dried probiotics are dissolved in sterile water to a volume of 1 ml which is ingested once daily, in the evening.

Eligibility criteria:
inclusion criteria: * previously diagnosed crohn's disease of the large bowel or large and small bowel according to established criteria. * at least one prior episode of active disease * stoolcultures and microscopies without pathogenic bacteria or parasites * cdai 220-400 * informed consent exclusion criteria: * more than 15mg of prednisolone daily (or equivalent) * changes in dosage of glucocorticoids during the last four weeks prior to inclusion * changes in dosage of azathioprine during the last 3 months prior to inclusion * antibiotic treatment during the last two months prior to inclusion * symptoms of crohn's disease assumed to be caused by mechanical obstruction og abscesses * long term treatment with nsaid or colestyramine * pregnant and lactating women * bowel resections removing more than 100 centimetres of small intestine or any colonic resection other than ileo-cecal resection

Keywords: probiotic
immunotherapy in uncommon and 20ins egfr-mut lung cancers

Conditions: Lung Cancer

Summary: immunotherapy effectiveness and optimal combination strategy in lung cancers with egfr uncommon and 20ins mutations was unclear. based on 627 lung adenocarcinoma patients harboring egfr mutations and receiving immunotherapy, we reported that patients with egfr uncommon mutations had better response to immunotherapy, than egfr 19del/l858r or 20in mutations. immunotherapy monotherapy or plus chemotherapy was identified as better combination strategy for egfr uncommon or 20ins mutations, respectively. higher tumor mutation burden, more m1 macrophage, less tregs and m2 macrophages infiltration, but not pd-l1 expression was found to be associated with egfr uncommon mutations, compared to egfr 19del/l858r or 20in mutations. these findings revealed diverse response and optimal combination strategy of lung adenocarcinoma patients harboring egfr mutation subtypes, promoting rethinking about current immunotherapy application and prolonging survivals of them.


Eligibility criteria:
inclusion criteria: 1. age≥18 years, 2. advanced or recurrent luad confirmed by pathology, 3. harboring egfr mutations confirmed by super amplification refractory mutation system (super-arms) or next-generation sequencing (ngs), 4. receiving anti-pd-(l)1 antibody therapy at least once, 5. radiologically evaluable according to response evaluation criteria in solid tumors, version 1.1 (recist v1.1) exclusion criteria: -
effect of statin therapy on disease progression in autosomal dominant polycystic kidney disease (adpkd)

Conditions: Polycystic Kidney, Autosomal Dominant

Summary: the purpose of this study is to determine whether the medication pravastatin will ameliorate renal and cardiovascular disease over a 3-year period in children and young adults with autosomal dominant polycystic kidney disease (adpkd).

autosomal dominant polycystic kidney disease (adpkd) is the most common hereditary kidney disease, affecting 1 in 400 to 1000 individuals and accounting for 4% of end-stage renal disease in the united states and 8-10% in europe. the condition is characterized by progressive development of kidney cysts with kidney enlargement and associated loss of kidney function. high blood pressure and cardiovascular disease are common in patients with adpkd. although the condition is often thought to affect primarily adults, it is clear that the disease can be present in the fetus and young children. this study was designed to determine if treatment with the medicine pravastatin can slow the progression of kidney and heart disease when initiated early in life in patients with adpkd. the investigators will assess differences between pravastatin and placebo study groups over the three-year study period with respect to: 1) total kidney volume as assessed by magnetic resonance imaging (mri); 2) left ventricular mass index as assessed by mri; 3) urinary albumin excretion; and 4) endothelial-dependent vasodilation as assessed by brachial ultrasound. a total of 110 subjects were enrolled in this research study. this study involved pediatric subjects because the investigators believe that early intervention is critical if they are to decrease the morbidity and mortality associated with this condition. if pravastatin is shown to be effective in ameliorating progression of renal and cardiovascular disease in this study, routine management of people with this condition will be drastically altered.

Eligibility criteria:
inclusion criteria: * age 8-22 years * autosomal dominant polycystic kidney disease * normal kidney function exclusion criteria: * abnormal kidney function * past allergic history to medications used in study * liver disease * muscle disease/dystrophy * pregnancy, planned pregnancy, or lactation within study period * inability to cooperate with or clinical contraindication for magnetic resonance imaging

Keywords: autosomal dominant polycystic kidney disease cystic kidney disease high blood pressure statin
implementing lisa surfactant in nigeria

Conditions: Respiratory Distress Syndrome; Neonatal Death

Summary: implement surfactant (bles®) replacement therapy using the less invasive surfactant administration technique in six tertiary institutions in nigeria and evaluate its impact on 72-hour neonatal mortality in premature infants born less than 2000 grams at birth.

background: in low- and middle-income countries (lmics), respiratory distress syndrome (rds) accounts for \~45% of all in-hospital neonatal mortality. surfactant use is limited in lmics, in part, due to the high cost, the lack of skill to perform laryngoscopy and tracheal intubation, and perhaps a perception that surfactant administration and mechanical ventilation must occur together. in lmics, continuous positive airway pressure (cpap) is often the highest mode of respiratory support available, and cpap failure invariably means death. if less invasive surfactant administration (lisa) can reduce cpap failure, as shown in high-income settings, it potentially can reduce prematurity-related neonatal mortality in lmics. there are, however, no studies on how to safely implement lisa in lmics. the lisa procedure is novel in lmics; the procedure is not without risk (severe and minor), laryngoscopy is a difficult skill to acquire, master, and maintain, and the resource limitations in lmics need consideration while implementing lisa. hypothesis: compared to a historical control, introducing non-invasive surfactant administration through the less invasive surfactant administration (lisa) techniques will result in a relative risk reduction of all-cause 72-hour in-hospital mortality by at least 20%. pico outline: population: preterm infants \ 4, who are spontaneously breathing, and on cpap. intervention: surfactant administered through the less invasive surfactant administration (lisa), technique. comparator: a historical control of preterm babies \ 4, who are spontaneously breathing, and on cpap. outcome measures: primary outcome: 72-hour all-cause in-hospital mortality. secondary outcomes * all-cause in-hospital mortality * change in respiratory distress score, pre- to -post interventions.

Eligibility criteria:
inclusion criteria: * newborns with birth weight between 500-2000 grams (determined by birth weight or admission weight if birth weight is unavailable). * ≤48 hours old at recruitment. * spontaneously breathing but have clinical signs of respiratory distress (defined by anderson silverman score (ass) ≥4 (range 0-10)) and on cpap. * admitted to the neonatal/newborn units (or special care nurseries). exclusion criteria: * any newborn intubated before admission to the neonatal/newborn units. * any newborn infants with a significant congenital abnormality * any preterm infant considered nonviable by the managing clinician.
mr- pet guided biologically optimised interstitial brachytherapy

Conditions: Cervical Cancer

Summary: the proposed two stage study will evaluate patterns of local recurrence after ebrt and brachytherapy in spatial reference to baseline functional mri and flt/f-miso pet scan in patients undergoing chemoradiotherapy for postoperative recurrences of cervical cancer. the first stage of the study will focus on developing mr guided interstitial brachytherapy and validating the concept of high risk gross tumor volume (on the basis of functional imaging features). the second stage thereafter will focus on developing biologically modulated interstitial brachytherapy. in the proposed two staged study the investigators intend to prospectively evaluate and validate concept of hrgtv and develop technique of biologically dose modulated brachytherapy. the demonstration of technical feasibility and clinical safety of biologically modulated image guided radiotherapy in this pilot study for may pave the way for improving local control in patients with postoperative recurrences.

aims stage i aim 1: to spatially characterize biologically heterogenous subvolumes within the gross tumor through multimodality (18 f-miso/flt/functional mr) image fusion. aim 2: to evaluate post external beam radiotherapy (ebrt) response in spatial reference to biological heterogeneous sub-volumes on imaging. stage ii: aim 3: to evaluate technical feasibility of delivering dose modulated biologically optimized interstitial brachytherapy. aim 4: to evaluate acute and late toxicity and quality of life associated with biologically optimized brachytherapy

Eligibility criteria:
inclusion criteria: * age \> 18 years. * ecog 0 or 1. * residual/ recurrent tumor after hysterectomy of cervical cancer. * no visceral metastasis. * no known contraindication to contrast enhanced mri/pet scan. * fit for radical treatment (radiotherapy+/-chemotherapy). exclusion criteria: * expected survival less than 3 years due to coexisting morbid medical conditions precluding radical chemoradiotherapy. * inguinal or extra-pelvic nodal metastasis (patients with common iliac nodal enlargement in the absence of paraaortic nodal metastasis on pet-ct may be included in the study).

Keywords: diffusion weighted mri flt pet f-miso pet image guided brachytherapy cervix postoperative residual disease/postoperative recurrences
vessel injury in relation with strut thickness assessed by oct

Conditions: Coronary Artery Disease

Summary: the objective of the present study is to determine the relation between vascular injury induced by the stent and strut thickness.

thinner struts produce less arterial injury after stent implantation.the objective of the present study is to determine the relation between vascular injury induced by the stent and strut thickness. vessel injury after stent implantation will be evaluated with optical coherence tomography (oct). two stents platforms with different strut thickness (coroflex isar 50 microns and biomatrix 120 microns) will be compared.

Eligibility criteria:
inclusion criteria: * patients older than 18 years * ischemic symptoms or evidence of myocardial ischemia (inducible or spontaneous) in the presence of \>50% de novo stenosis located in native coronary vessels exclusion criteria: * target lesion located in the left main stem * stemi * restenosis * cardiogenic shock * malignancies or other comorbid conditions with life expectancy less than 12 months or that may result in protocol noncompliance * known allergy to the study medications (probucol, sirolimus, zotarolimus) * pregnancy (present, suspected, or planned)
12-week no-rofecoxib plus aspirin endoscopy study (0782-003)

Conditions: Arthritis, Rheumatoid; Osteoarthritis

Summary: this study will look at the incidence of gastric and/or duodenal ulcers in patients with osteoarthritis or rheumatoid arthritis in four different treatment groups (a) mk0782 21 mg plus enteric-coated aspirin, (b) mk0782 42 mg plus enteric-coated aspirin, (c) celecoxib 200 mg plus enteric-coated aspirin, and enteric-coated aspiring alone. this is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (full information is available to trial participants).


Eligibility criteria:
inclusion criteria: * has osteoarthritis or rheumatoid arthritis for at least 6 months prior to start of study * osteoarthritis (oa): must have diagnosis of oa in knee, hip, hand or spine patient is not on chronic aspirin therapy (taking aspirin at any dose, on a daily basis, for a minimum of 4 weeks prior to visit 2 for any medical condition * must be willing to limit alcohol use to no more than 2 drinks per day * avoid strenuous physical activity exclusion criteria: * mentally or legally incapacitated * has systemic lupus erythematosus, paget's disease * has a history of esophageal, gastric biliary, or small intestine surgery (hiatal surgeries and any gi surgery that causes clinical malabsorption or delayed gastric emptying * has uncontrolled hypertension * has uncontrolled diabetes * has had heart attack, unstable angina, coronary angioplasty, stent placement, coronary artery bypass grafting in the last 6 months * has congestive heart failure * has had active liver disease within the last 2 years
specific dietary pattern for crohn's disease patients following surgery

Conditions: Crohn Disease

Summary: over the past 10 years, there are a large number of dietary treatments related to the cd, such as specific carbohydrate diet, low fermentable oligo-, di-, mono-saccharides and polyols (fodmap) diet, and allergen-free foods. but there is no consistent conclusion or convincing evidence about the effectiveness. through the long-term clinical experience observation, we find most of the cd patients can get stable remission by removing refined food and intolerance food.this project aims at developing a new dietary therapy suitable for chinese patients.

the dietary therapy is based on the nutrient composition of exclusive enteral nutrition and is more in line with chinese patients' dietary habits and economic conditions.

Eligibility criteria:
inclusion criteria: 1. diagnose cd according to endoscopy, histology and imaging; 2. bowel resection for cd 3. oral nutritional preparations or food can be given after surgery exclusion criteria: 1. plan operation within 5 weeks after surgery; 2. presence of an ileostomy or colostomy 3. complete bowel obstruction or fibrous stricture 4. pregnancy or breastfeeding; 5. plan to use biological agents within 5 weeks after surgery; 6. plan to use corticosteroids or prednisone greater than 20 mg per day or equivalent doses of drugs to maintain remission within 5 weeks after surgery; 7. plan to use probiotics or prebiotics for more than 1 week after surgery; 8. antibiotics are used for more than 2 weeks after surgery; 9. hypersensitivity to known components of enteral nutrition; 10. bmi less than 14 or greater than 28 kg/m2; 11. celiac disease; 12. complicated with other autoimmune diseases such as diabetes or rheumatic disease, autoimmune liver disease, psoriasis; 13. mental illness; 14. malignant tumors 15. those who are not suitable for body composition analysis (such as pacemakers and metal objects in the body) 16. participating in other clinical trials 17. the researcher believes that others are not suitable to participate in this study.

Keywords: dietary pattern, crohn disease
effect of inhaled molecular hydrogen on recovery process after downhill walking on the treadmill

Conditions: Muscle Soreness; Muscle Fatigue; Oxidative Stress; Inflammation

Summary: this study assesses the effect of molecular hydrogen inhalation in healthy males on muscle soreness, fatigue, oxidative stress, and inflammation following eccentric muscle contraction during downhill walking on the treadmill.

the main aim of this randomized, double-blind, placebo-controlled crossover study is to assess the effect of molecular hydrogen inhalation on recovery after downhill walking with an additional load of 15% of body mass on the treadmill with a negative slope of -15% at a speed of 6.5 km/h for 90 min. the study includes 12 participants, healthy males aged 20-35 years. the study consists of two experimental sessions, one using molecular hydrogen inhalation and the other using placebo inhalation. randomization is performed using a computer random generator. molecular hydrogen is colourless, odourless, and tasteless, so it cannot be distinguished from placebo by the human senses. the washout period between sessions is set at four weeks. one week before each session, participants are asked to follow diet and physical activity rules. variables measured during the 48 h recovery are as follow: creatine kinase level, perceived muscle soreness, reactive strength index, malondialdehydes level, and interleukin-6 level. the following variables are also measured during exercise: heart rate, ventilation and gas exchange, and blood lactate level. analysis of variance for repeated measures and fisher's post hoc tests are used for statistical analysis. the significance level is set at 0.05.

Eligibility criteria:
inclusion criteria: * free of major diseases. * completed questionnaire sudden cardiovascular death in sport: lausanne recommendations. * signed informed consent. exclusion criteria: * acute conditions contraindicating laboratory testing of sports performance. * hypertension. * dyslipoproteinaemia. * cardiorespiratory disease. * pharmacotherapy affecting heart rate. * musculoskeletal problems.
the evaluation of safety and efficacy of jwhgwt on diabetic neuropathy

Conditions: Diabetic Neuropathy

Summary: in order to provide a alternative treatment for relieving the pain and numbness of diabetes mellitus patients,traditional chinese medicine powder was tested by subjective questionnaire and objective nerve conduction velocity study. liver and kidney functions were tested to provided safety profiles.

120 participants with diabetic neuropathy were screened in endocrine and metabolism clinics of taichung veterans general hospital and chinese medical university hospital . subjects were randomly distributed into a double-blind, 12 weeks, placebo-controlled procedure. subjects were measured by mnsi, sf-bpi, sf-36, sf -mcq, ncv, ac sugar, hba1c, lipid profiles, liver and kidney functions. safety evaluations including gpt and creatinine revealed no deterioration after treatment. several domains in mnsi, sf-bpi, sf-36, sf -mpq questionnaires revealed significant improvements. f-wave in peroneal, tibial nerves and distal latency in tibial nerve in objective nerve conduction studies revealed significant improvements.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of dm * must have the symptoms of pain or numbness exclusion criteria: * patient with pregnancy (or child bearing potential),or in lactation * patient currently taking concomitant tcm medications. * patient with drug or alcohol addiction * patient with medical history of myocardial infarction, cerebro-vascular disease, major trauma, operation 6 months prior to enrollment * patient with liver dysfunction (sgot or sgpt\>2x uln) * patient with renal insufficiency (serum creatinine\>1.3mg/dl)

Keywords: diabetic neuropathy nerve conduction studies clinical trial