Kornimate/medical-research-clean huggingface dataset:
flavopiridol in treating patients with chronic lymphocytic leukemia

Conditions: B-cell Chronic Lymphocytic Leukemia; Refractory Chronic Lymphocytic Leukemia; Stage I Chronic Lymphocytic Leukemia; Stage II Chronic Lymphocytic Leukemia; Stage III Chronic Lymphocytic Leukemia; Stage IV Chronic Lymphocytic Leukemia

Summary: phase ii trial to study the effectiveness of flavopiridol in treating patients who have chronic lymphocytic leukemia that has not responded to treatment with fludarabine. drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die

objectives: determine the complete and partial response rate to flavopiridol in patients with fludarabine-refractory chronic lymphocytic leukemia. assess the toxicity profile of this treatment in these patients. examine progression-free survival and overall survival following this treatment in these patients. determine the effects of flavopiridol on normal t-cell subsets and immunoglobulin levels in these patients. outline: this is an open label, multicenter study. patients registered before 9/15/2000 receive flavopiridol iv continuously on days 1-3. treatment repeats every 14 days for a total of 12 courses in the absence of disease progression or unacceptable toxicity. patients registered after 9/15/2000 receive flavopiridol iv over 1 hour daily on days 1-3. treatment repeats every 3 weeks for a total of 8 courses in the absence of disease progression or unacceptable toxicity. patients are followed every 3 months for the first year and then every 6 months for 5 years.

Eligibility criteria:
inclusion criteria: * histologically diagnosed intermediate risk (stage i or ii) or high risk (stage iii or iv) refractory b-cell chronic lymphocytic leukemia * intermediate risk group must have evidence of active disease as shown by at least one of the following: * massive or progressive splenomegaly and/or lymphadenopathy * weight loss of greater than 10% in the last 6 months * calgb grade 2-4 fatigue * fevers greater than 100.5 degree fahrenheit or night sweats for greater than2 weeks without evidence of infection * progressive lymphocytosis with an increase greater than 50% over a 2 month period or an anticipated doubling time of less than 6 months * refractory to fludarabine treatment or relapsed within 6 months of fludarabine * lymphocytosis greater than 5000/mm3 at some time during disease * bilirubin no greater than 1.5 times upper limit of normal (uln) * creatinine no greater than 1.5 times uln * not pregnant or nursing * fertile patients must use effective contraception * no more than 1 prior nonradiolabeled antibody treatment (e.g., campath-1h or rituximab) * at least 1, but no more than 3, prior chemotherapy regimens * at least 1 prior chemotherapy regimen comprising fludarabine * no other concurrent chemotherapy * no concurrent chronic use of oral corticosteroids * no concurrent hormone therapy except for non-disease related conditions * no concurrent dexamethasone or other corticosteroid-based antiemetics * no concurrent palliative radiotherapy
transurethral vapor enucleation resection of the prostate (tverp), bipolar turis and holep

Conditions: Benign Prostatic Hypertrophy

Summary: to verify the safety and efficacy of the use of the plasma vaporisation button in transurethral vapor enucleation and resection of the prostate (tverp) for treatment of benign prostatic hypertrophy (bph) patients with prostate ˃30 and ≤80 ml compare to turis or holep surgery methods.


Eligibility criteria:
inclusion criteria: 1. male, age older than 22 and younger than 75 years of age 2. the patient should be a candidate for surgical treatment of bladder outlet obstruction. 3. patients with bph and surgical indication (refractory to medical treatment, refractory or recurrent urinary retention, recurrent haematuria, bladder stones, recurrent infections, hydronephrosis) 4. prostate volume ˃30 and ≤80 ml 5. psa \<4 ng/ml in patients above 55 years old and a prostate cancer risk less than 35%. (prostate cancer risk calculator). 6. ipss ≥8 (moderate to severe) 7. indications for turis 8. maximum urinary flow (qmax) \<10ml/second 9. a written informed consent signed by the patient (including patient's agreement to randomization and treatment). exclusion criteria: 1. patients under anti-inflammatory or steroid therapy 2. patients under anti-coagulation at a level that could be exposed to a very high risk of complications based on a comprehensive pre-operatory evaluation. 3. renal insufficiency serum creatinine (scr) \>1.5 x upper limit of normal (uln); ast and alt\>2.5 x uln;total bilirubin \>1.5 x uln 4. previous neurogenic lower urinary tract dysfunction. 5. patients with urethral strictures 6. severe pulmonary disease and cardio-vascular disorder 、coagulopathy，and contraindications to anesthesia and surgery. 7. concurrent participation in any other clinical study 8. any of the following within the 12 months prior to study: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack and 6 months for deep vein thrombosis or pulmonary embolism. 9. previous bladder outlet surgery. 10. a clinically significant acute illness. 11. intake of medication in which the principle investigator considers to preclude enrollment into the trial. 12. known disease of the central or peripheral nervous system. 13. any clinical evidence of carcinoma of the prostate. 14. hiv positive or any other immunosuppressive disorder. 15. psychological/psychiatric disease /known cognitive disorder.
preventive osteopathic treatment of plagiocephaly

Conditions: Positilonal Deformation of the Skull; Head Turn Preference; Axial Hypertony

Summary: positional cranial deformities (pcd), plagiocephaly and brachycephaly are a common reason for pediatric consultation, which has increased significantly since the recommendation to lay babies on their backs to prevent unexpected infant death (ild). cpd is a source of concern for parents about their impact on psychomotor development and the aesthetic risk of deformity. the high authority for health (has) will soon put in place recommendations with a fact sheet for health professionals and the public. the aim of this research is to study whether early treatment of rotation disorders and hypertonia in newborns by manual osteopathic techniques would prevent the occurrence of positional deformities of the skull. the main objective is to evaluate the effectiveness of an early osteopathic treatment on the rate of cpp (plagiocephalic and postural brachycephalia) at 4 months in newborns at risk. the secondary objective is: to evaluate the effectiveness of an early osteopathic treatment on the quality of life of the child at 4 months. methodology: controlled, randomized monocentric two-arm parallel study between (1) osteopathic follow-up and (2) osteopathy-free follow-up. the inclusion period will be 18 months and the follow-up period is 4 months. procedure: the two groups will be evaluated at 3 days and 4 months. the experimental group will benefit from an osteopathic treatment of 3 days of life to 4 months with a frequency of 3 to 4 sessions. both groups will benefit from sleeping, carrying, positioning and stimulation advice. the perspectives are: * the decrease in the prevalence of cpp after early osteopathic treatment. * defining a decision algorithm for early osteopathic treatment. * subject to recommendations on the indication of early osteopathic treatment in neonates at risk.


Eligibility criteria:
inclusion criteria: * newborn baby aged 3 days and until the maternity leave * newborn with at least one risk factor for cranial deformity: * newborn who received instrumental vaginal delivery. * newborn presenting: * a preferential side, * global axial hypertonia, * localized suboccipital hypertonia * newborn presenting: * cranial deformity at birth, * a deformation of the face, * deformity of the trunk in scoliosis, comma or hyperextension exclusion criteria: * newborn with congenital muscular torticollis (managed directly in physiotherapy) * premature neonate (\<37sa) * newborn with a malformation pathology * newborn with craniosynostosis. * newborn with a contraindication to the practice of osteopathy.
effects of different polyphenol-containing beverages on the immune system and on muscular growth factors

Conditions: Food Sensitivity

Summary: in this research project, the effect of different polyphenol-containing beverages with varying alcohol content of \< 0.4 vol% on immune function as well as muscular growth factors will be investigated


Eligibility criteria:
inclusion criteria: * healthy * age 20 - 60 years * written informed consent exclusion criteria: * severe gastrointestinal disease or known malabsorption * use of proton pump inhibitors * malignancies * rheumatoid diseases * metabolic syndrome * acute or chronic infections or inflammatory diseases * use of medications or supplements to interfere with immune function * alcohol and/or drug abuse or addiction * dependent relationship with the project manager or his or her employees * pregnancy or breastfeeding * chronic illness or regular use of medication (except hormonal contraception) * smoker
home use of mechanical insufflation/exsufflation devices in neuromuscular diseases

Conditions: Neuromuscular Diseases

Summary: with this cross-sectional study of adult subjects with neuromuscular disease in the french-speaking part of switzerland, we aim to explore mi-e adherence using self-report questionnaires and device data in order to identify the factors that influence the pattern of mi-e use and satisfaction with the treatment. determining potential barriers to regular long-term home use of mi-e could help in identifying the patients who would benefit most from this therapy.


Eligibility criteria:
inclusion criteria: * age over 18 years * diagnosis of neuromuscular disease * active prescription of mi-e for more than 3 months exclusion criteria: -invasive airway

Keywords: mechanical insufflation-exsufflation cough assistance
effect of artificial tears on biometry

Conditions: Cataract

Summary: the purpose of this study is to determine if measurements for cataract surgery are improved with use of additional lubrication with artificial tears. the research study is being done to optimize measurements and provide patients with the best visual outcomes after cataract surgery.


Eligibility criteria:
inclusion criteria: * male or female ≥ 18 years of age * documentation of bilateral age-related senile cataracts diagnosis exclusion criteria: * patients currently using regularly scheduled artificial tears. patients with infrequent or irregular use of artificial tears may not be excluded from the study. * patients using contact lenses. * patients with any other surface pathology affecting corneal biometric measurements determined with slit-lamp examination or medical history.

Keywords: biometry measurement artificial tear cataract surgery
evaluation of the moreno score for the regulation

Conditions: the Safety / Feasibility /MORENO Score/Regulation / Secondary Transfers / SAMU 29 / Current Practices

Summary: the main objective of this work is therefore to evaluate the safety and feasibility of the moreno score for the regulation of secondary transfers to the samu 29 compared to current practices.

today, there is an increase in the number of secondary transfers and paramedical transport between the different hospitals in a territory. they have been promoted by the sfmu (french society of emergency medicine) since 2012. the sharp increase in the number of calls for samu regulation means that decisions must be made quickly and safely regarding transport requiring or not requiring a medical presence. the development of a decision support tool for the level of medicalisation of a transfer therefore seems necessary. however, there is currently no recommendation in france. the moreno score has already been used in a hospital in the var, as well as in spain and greece. prior validation of this score in our health territory is essential before setting up an operational procedure. using a list of simple clinical items, this score enables us to assess whether or not it is necessary to medicalise a transfer.

Eligibility criteria:
inclusion criteria: * all adult patients having benefited from a transfer regulated by the samu 29 of adult patients on the finistère territory over a predefined period of time exclusion criteria: * pediatric patient transfers * maritime transfers * transfers for which the collected information does not allow to establish the moreno score. * patients under judicial protection (guardianship, curatorship,..) * opposition
onetouch verio flex system accuracy evaluation

Conditions: Diabetes Mellitus

Summary: clinical system accuracy evaluation of the ce marked one touch verio flex blood glucose monitoring device as per requirements stated in iso 15197:2015. to meet the requirements, glucose samples must be distributed over the operating range of the blood glucose monitor as stipulated in iso:15197

clinical system accuracy evaluation of the ce marked one touch verio flex blood glucose monitoring device as per requirements stated in iso 15197:2015.

Eligibility criteria:
summary of inclusion criteria: * all subjects must be registered into the lfss patient registry to participate in the study. * each participant must read and sign the approved informed consent form. * diabetes diagnosis - participants should be diagnosed with some form of diabetes for system accuracy. summary of exclusion criteria: \> subjects not enrolled in the lfss patient registry are not eligible to participate in the study.

Keywords: blood glucose monitor system accuracy
esophageal ph-mii duration: 12 or 24 hours?

Conditions: Gastro Esophageal Reflux

Summary: to check whether the first 12 hours of mii-ph recording are sufficient to diagnose gastroesophageal reflux disease (gerd) among newborns/infants, with a diagnostic accuracy similar to 24 hours of recording as currently advised.

the results of the 24 hour mii-ph recording will be compared to those from the first 12 hour of the same study. to this end the study investigators will select the first 12 hour of the recording using the manufacturer's software (diversatek zvu advanced gi diagnostic software). published normal reference values will be used to confirm gastroesophageal reflux (ger). appropriate statistical methods will be used to perform calculations. subgroup analyses based on preterm birth, presence of bronchopulmonary dysplasia and type of prevalent ger symptom (respiratory or gastrointestinal) will be performed.

Eligibility criteria:
inclusion criteria: * 24 hours mii-ph performed for suspected ger exclusion criteria: * major malformations * previous thoraco-abdominal surgery, gastrostomy, anti-gerd therapy (thickeners, alginates, h2 blockers, proton pump inhibitor - ppis, etc.) in the 7 days preceding the mii-ph, * ventilatory support (invasive or non-invasive) at the time of the mii-ph
arthroscopic autologous chondrocyte implantation versus microfractures

Conditions: Tear; Knee, Cartilage, Articular

Summary: this is a phase iii, randomised controlled trial of matrix-encapsulated chondrocyte implantation procedure compared to the microfracture procedure in the repair of symptomatic cartilage lesions of the knee. eligible patients were asked for informed consent preoperatively and randomised for chondrocyte implantation of microfractures. those patients allocated to the chondrocyte implantation group will be harvested at time of first arthroscopic procedure and concurrent lesions were treated, as meniscus repair, ligament reconstruction, or malalignment corrected. the patients allocated to microfracture will be treated at the time of the only arthroscopic procedure. both groups will have the same rehabilitation program. prospective clinical, radiographic and magnetic resonance imaging will be performed as main outcomes.


Eligibility criteria:
inclusion criteria: * patients with symptomatic single chondral lesions of the knee from 1 to 4 cm2. * signed patient informed consent. * agree to adhere to rehabilitation protocol. exclusion criteria: * inflammatory arthritis, septic arthritis, gout, pseudogout, paget's disease, ochronosis, acromegaly, hemochromatosis, tumors, collagen mutations. * total meniscectomy * malalignment * evidence of osteoarthritis

Keywords: cartilage articular
pharmacokinetics of single-dose oral ranolazine in hemodialysis patients

Conditions: End-stage Renal Disease; Cardiovascular Disease

Summary: end-stage renal disease (esrd) patients often develop cardiovascular complications, and cardiovascular disease is the leading cause of death in this population. ranolazine's ability to treat angina without reducing heart rate or blood pressure makes it an important option for esrd patients. the hemodialysis clearance of ranolazine is unknown. a single-dose pharmacokinetic study is needed to characterize ranolazine and its metabolites in esrd patients on and off hemodialysis. results of the proposed study will provide initial dosing estimates for a follow-up, multiple-dose pharmacokinetic study in this population.


Eligibility criteria:
inclusion criteria: * 18-74 years of age * within 50% of ideal body weight and greater than 40 kg * chronic kidney disease (ckd) stage 5 receiving maintenance hemodialysis for at least 3 months * native kidney estimated glomerular filtration rate(gfr) \< 10 ml/min * no concurrent illness or evidence of infection * able to give informed consent exclusion criteria: * qtc interval \> 470 msec at echocardiogram (ecg) obtained within the last 6 months * concomitant qt-prolonging drugs, major p-gp inhibitors, and cyp3a4 inducers and inhibitors including: cyclosporine, rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine, st. john's wort, ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, saquinavir, quinidine, dofetilide, sotalol, amiodarone, erythromycin, thioridazine, ziprasidone, haloperidol, trimethoprim/sulfamethoxazole, ciprofloxacin, norfloxacin, levofloxacin, moxifloxacin * pre-study hemoglobin \< 9.5 g/dl * plasma albumin \< 2.5 g/dl * liver disease - exclude subjects with a child pugh score of c or higher * positive pregnancy test * breastfeeding * allergy to ranolazine * participating in another investigational study * hepatitis b infection due to dialysis isolation requirements * unstable blood pressure control * need for routine large fluid removal during dialysis (\> 4l)

Keywords: ranolazine end-stage renal disease pharmacokinetics cardiovascular disease
psychoeducational group for depression

Conditions: Major Depressive Disorder (MDD

Summary: the study aims to investigate the efficacy of a psychoeducational program as an adjunctive treatment for depression. the study will involve 338 patients diagnosed with major depressive disorder (mdd) of moderate severity. participants will be randomly assigned to receive either treatment as usual (tau) alone or tau plus the psychoeducational program. the program consists of six weekly group sessions covering information and techniques for coping with depression. primary outcomes include a reduction in depressive symptoms measured by the beck depression inventory-ii (bdi-ii) and increased knowledge of depression. secondary outcomes include improvements in functionality and quality of life. the study aims to provide insights into the effectiveness of psychoeducation in improving outcomes for individuals with depression


Eligibility criteria:
inclusion: * both sexes; * ages between 18 and 65 years old; * diagnosis of major depressive disorder (mdd) made by a clinician according to diagnostic statistical manual criteria-5-text revised (dsm-5-tr) * patients with hamilton depressive rating scale-17 items (hdrs-17) scores 14-23; * informed and signed consent form. exclusion: * unstable serious clinical or neurological diseases; * postpartum depression or other types of depressive disorders (disruptive mood dysregulation disorder, pre-menstrual, substance/medication-induced depressive disorder, depressive disorder due to another medical condition, another disorder specified depressive disorder and unspecified depressive disorder); * other psychiatric disorders; * patients with active psychotic symptoms; * suicidality risks * patients already undergoing any other psychological treatment for mdd; discontinuation: * more than two absences during treatment; * those who miss more than two sessions/consultations, whether medical treatment or the psychoeducational program; * non-response to the use of sertraline over the initial eight weeks; presence of hypomanic symptoms at any time during treatment (young \&lt;7)
mean systemic filling pressure trends in liver transplant recipients

Conditions: Liver Transplant; Complications; Liver Diseases; Hemodynamic Instability

Summary: patients with end stage liver disease undergoing liver transplantation have varying degrees of intraoperative haemodynamic unstability during various phases of transplantation. it is difficult to determine the cause for hemodynamic instability in these patients and to predict the best treatments. currently, cardiovascular resuscitation options are triggered by arterial pressure and cardiac output (co) measures, focusing on the oxygen delivery side of the circulation. the primary determinants of cardiac output reside on the venous side. veins are 30-50 times more compliant than arteries and contain approximately 75% of the total blood volume. mean systemic filling pressure provides vital information on this venous side of the circulation. mean systemic filling pressure , which is defined as the pressure equal to the pressure which would be measured if the heart should suddenly stop pumping and all (arterial and venous) the pressures in the entire circulatory system should be brought to equilibrium instantaneously, is a good, complete and reliable reflection of the total intravascular fluid compartment. we would study the mean systemic filling pressure in liver transplant recipients and record hemodynamic, respiratory, cardiac and renal function prospectively. follow up data for 7 days for respiratory, cardiac and renal complications will be collected, along with hospital stay, icu stay and mortality. the association between mean systemic filling pressure and these outcomes will be analyzed.


Eligibility criteria:
inclusion criteria: * all patients undergoing liver transplantation 18-65 years exclusion criteria: * pregnant patients acute liver failure, acute on chronic liver failure

Keywords: liver transplantation mean systemic filling pressure advanced hemodynamic monitoring liver cirrhosis
enteropathogenic escherichia coli (epec): does it have a role in colorectal tumourigenesis?

Conditions: Enteropathogenic Escherichia Coli .; Colorectal Carcinoma

Summary: despite the characterization of many aetiologic genetic changes. the specific causative factors in the development of sporadic colorectal cancer remain unclear. this study was performed to detect the possible role of enteropathogenic escherichia coli (epec) in developing colorectal carcinoma.

fresh biopsy specimens have been obtained from the colonic mucosa overlying the colorectal cancer as well as from the colon of the healthy controls. culture, genotyping and virulence of epec were done using (nutrient broth culture, and pcr). strains biochemically identified as e. coli were selected from the surface of a macconkey's plate and were serogrouped by slide agglutination tests

Eligibility criteria:
inclusion criteria: * patients with colorectal carcinoma after have been diagnosed exclusion criteria: * patients with inflammatory bowel disease (ibd) or macroscopic signs of inflammation were excluded.