Kornimate/medical-research-clean huggingface dataset:
quality assessment creatinines in plasma and urine

Conditions: Chronic Kidney Disease

Summary: in clinical practice the 24-hour creatinine clearance is often used to obtain an impression of renal function. however, the glomerular filtration rate is considered to be the best indicator of renal function. for practical and financial purposes, gfr is often estimated by means of serum creatinine based equations. these equations are also used in internation guidelines to define and classify chronic kidney disease. therefore, accurate creatinine measurements are important to make reliable estimates of renal function. however, previous research has revealed a large variability in creatinine measurements using different measuring methods. in this study the investigators aim to establish the degree of variability in different methods to measure creatinine in a heterogenous group of caucasian people with and without renal function loss and the influence of this variability on renal function estimating equations and the 24-hour creatinine clearance.

apart from the 24-hour creatinine clearance, also formulas to estimate the glomerular filtration rate (gfr) are increasingly used to get an impression from renal function in recent years. based on these renal function measurements, clinical decisions are made as well as drug dose adjustments. the use of reliable serum creatinine measurements is therefore important to get accurate renal function estimates. however, serum creatinine is one of the most variable routine laboratory tests. the importance of calibration to a traceable reference measurement of serum creatinine has been stressed. however, this standardization does not correct for analytical non-specificity problems, which occurs in certain techniques to measure creatinine, leading to under- or overestimation of the true creatinine concentration. the aim of this cross-sectional observational study is to examine the degree of variability between diverse methods to measure creatinine in plasma and urine in a heterogenous group of caucasian people with and without renal function loss and the influence hereof on the 24-hour creatinine clearance and the modification of diet in renal disease study equation and the consequences for chronic kidney disease staging.

Eligibility criteria:
inclusion criteria: * all patients \>18 years presenting at the laboratory facility for a 24-hour creatinine clearance, or * persons \>18 years, undergoing a renal replacing therapy by means of hemo-/peritoneal dialysis that had a kt/v appointment between may 2010 - january 2011 exclusion criteria: * patients \<18 years

Keywords: creatinine chronic kidney disease creatinine clearance estimated glomerular filtration rate
efficacy and safety study of an antiarrhythmic drug to treat atrial fibrillation in patients with pacemakers

Conditions: Atrial Fibrillation

Summary: the purpose of this study is to determine the safety and efficacy of an investigational antiarrhythmic drug (ati-2042) in the treatment of atrial fibrillation in patients with a dual chamber pacemaker.

ati-2042 is being developed as an alternative to amiodarone, which is considered a first-line therapy for patients with atrial fibrillation and is known to have serious side effects. ati-2042 was designed to have a reduced plasma half-life and a lower volume of distribution, which is expected to result in an improved safety profile. in contrast to amiodarone, ati-2042 undergoes rapid metabolism via plasma and tissue esterases, which may reduce tissue accumulation and toxicity. the current trial will determine if ati-2042 retains the efficacy profile of amiodarone without the side effects attributable to tissue accumulation seen with long-term dosing. this study is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (full information is available to trial participants.)

Eligibility criteria:
inclusion criteria: * proven paroxysmal atrial fibrillation * pacemaker with appropriate af diagnostics and recording capabilities exclusion criteria: * known allergy to amiodarone or previous treatment for severe amiodarone toxicity * cardioversion within one month of screening * severe left ventricular dysfunction or chf with nyha class iii or above
rehabilitation of patients with modic changes in the lumbar spine

Conditions: Low Back Pain

Summary: the purpose of this study is to compare patients with low back pain (lbp) and modic changes from the backcenter funen, ringe: 1. to compare the effect of two types of non-operative treatments: a. exercise and advice to be physically active b. restitution and advice not to overload the spine 2. to investigate if the results of the treatment are influenced by gender, age, smoking, and physical load.

the clinical experience is that many patients with modic changes have relatively severe and persistent lbp, which typically appears to be resistant to treatment. furthermore, a retrospective study at the backcenter funen, ringe, shows that patients with mc fail to improve engaging physical activity. this is unfortunate, because the typical rehabilitation for patients with persistent lbp is back exercises and information about keeping physically active. this means that this relatively large subgroup of patients with modic changes probably does not improve with the rehabilitation tools used today. a randomised controlled trial has therefore been designed to study the specific subgroup of patients with modic changes. in this study we will compare the present "state-of-the art" rehabilitation approach to persistent lbp (namely to exercise and keep active) with a new concept (restitution). the justification for this is that restitution reduces mechanical stress on the vertebrae and therefore would allow heeling of the possible micro fractures in modic changes.

Eligibility criteria:
inclusion criteria: primary inclusion criteria for receiving mri * the patient must have lbp with a current duration of 3 - 12 month. * the patient must have an actual pain intensity ≥4 on numerical pain rating scale from 0-10. secondary inclusion criteria for receiving mri * the patient must speak and understand danish. * the patient must be between 18-60 years of age. * the patient must be willing to participate in the project. inclusions criterium for the project * there must be an mri showing mc in the lumbar spine. exclusion criteria: * the patient is unable to go through with the project because of other physical or mental disorder. * the patient is pregnant. * the patient is referred to operation.

Keywords: low back pain modic changes
angiotensinogen gene and human hypertension

Conditions: Cardiovascular Diseases; Heart Diseases; Hypertension

Summary: to determine the role of the angiotensinogen gene in human hypertension.

background: essential hypertension affects at least 25 percent of american adults, and it is a primary risk factor for heart failure, stroke, and kidney disease. many, but not all, studies have shown that variants of the angiotensinogen gene (agt) affect the risk of hypertension, but association studies conducted to date have been compromised by genetic heterogeneity and by the inherent complexity of hypertension as a phenotype. design narrative: a comprehensive study of the angiotensinogen (agt) gene will be conducted in data collected from several large groups of individuals. the investigators will sequence or genotype a 14.4 kb region including agt in more than 1,600 individuals sampled from populations throughout the world. this will permit them to explore fully the extent of allelic heterogeneity, haplotype variation, and potential for population stratification in the agt gene. approximately 600 of these individuals are clinically uncharacterized and will represent a broad range of worldwide human variation. another 500 subjects are members of 40 utah pedigrees that are part of the centre d'etude du polymorphisme humain (ceph) collection. these unique families have been heavily characterized genetically, and they are now being phenotyped for variables that include anthropometrics, blood chemistries, blood pressure measures, and plasma and urinary angiotensinogen. they will address the issue of genetic heterogeneity by testing associations between multi-snp agt haplotypes, angiotensinogen levels, and blood pressure. in addition, linkage disequilibrium patterns will be assessed to determine the density and nature of snps best suited for localizing a gene underlying a complex trait. they will address the issue of phenotypic heterogeneity in hypertension by performing extensive snp typing on a set of 400 hypertensives and 100 normotensives collected by dr. gordon williams. these clinically well-characterized subjects have been tested for their response to infused angiotensin-ii under high and low sodium intake. this direct probe provides a hypertension endophenotype that is closer to the function of the agt gene, yielding a more realistic and informative assessment of the relationship between agt haplotype variation and hypertension risk. a phylogenetic analysis of agt sequence variation in the worldwide sample will help to assess population stratification in association studies. in addition, this sample will allow testing the hypothesis that the ancestral t235 agt allele provided a selective advantage in the sodium-poor environment of sub-saharan africa. the results of this analysis may help to explain why african-americans have elevated rates of hypertension. in summary, the extensive analysis of agt variation in more than 1,600 subjects will clarify the role of this gene in essential hypertension and will test specific hypotheses about the evolution of agt.

Eligibility criteria:
no eligibility criteria
ambulatory oximetry monitoring (aom): a new approach to quantify oxygen desaturation in ambulatory copd patients

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: chronic obstructive lung disease (copd) is characterized by airflow obstruction that is progressive over many years and is largely irreversible. advanced copd is associated with arterial oxygen desaturation leading to a series of complications and, ultimately, decreased survival. long-term oxygen therapy can improve clinical outcomes in these patients, but the exact target of oxygen saturation that actually translates into improvements is not known. the basis for the work in this proposal is to focus a new approach to measure oxygen desaturation linked to daily activity. accelerometers are used to measure daily activity and then synchronized with ambulatory oximetry to establish an activity/oxygen-saturation profile for individual patients. the three main objectives of this study are 1) determine the feasibility of aom as a measurement of the temporal profile of oxygen saturation in patients with chronic lung disease; 2) determine if serial aom-derived data is reliable and reproducible; and 3) determine thresholds of oxygen desaturation that are associated with different activity profiles


Eligibility criteria:
inclusion criteria: 1. veteran patients with a diagnosis of copd or other chronic lung disease 2. able to read and understand english 3. \> 45 years old 4. ambulatory and able to perform functional testing exclusion criteria: 1. unable or unwilling to give informed consent 2. daily use of a motorized cart 3. impairment of cognition or communication 4. history of drug or alcohol treatment within the past 6 months 5. poor peripheral blood flow to the finger rendering oxygen saturation by pulse oximetry unreliable 6. recent acute medical events (chest pain, discomfort, etc) that would suggest a contraindication to participate at the scheduled time

Keywords: oximetry physical activity
clinical evaluation of polytetrafluoroethylene (ptfe, matfill) for the sealing of prosthetic chimneys.

Conditions: Edentulous Alveolar Ridge

Summary: dental implant supported screwed prosthetic rehabilitations are associated to several advantages, as a minimal occlusal spaced and easier hygiene and maintenance. in this sense, screwed rehabilitations have been associated with lower frequency of biological and technical complications. nevertheless, the screwing process results in the formation of a prosthetic chimney that requieres an appropriate sealing protocol. this protocol needs to include a material for the protection of the screw head. nowadays, there is a lack of materials for this intended use with marketing authorisation. several materials have been tested in the bibliography including ptfe, although there are not high quality studies. in this context, this clinical investigation aims to evaluate the efficacy and safety os a ptfe-based product (mafill) for the sealing of prosthetic chimneys and the protection of the screw head.


Eligibility criteria:
inclusion criteria: * age \> 18 years old * clinical need for the placement of a implant-supported dental prosthesis * clinical need for the filling of the prosthetic chimney * signing informed consent exclusion criteria: * inability of follow-up
prevalence of dvt or pe in patients infected with covid-19 admitted to hospital

Conditions: COVID-19

Summary: the main objectives are: * to establish the prevalence of deep venous thrombosis through ultrasonography in patients infected with covid-19 admitted to hospital. * to identify patients with higher risk of deep venous thrombosis.


Eligibility criteria:
inclusion criteria: * patients infected with covid-19. * admission to hospital. exclusion criteria: * patients treated with ecmo (extracorporeal membrane oxygenation).
the effect of pre-washing the insemination catheter on pregnancy outcome

Conditions: Infertility; Pregnancy

Summary: the investigators hypothesize that washing the insemination catheter prior to performing the iui (intrauterine insemination) will improve the pregnancy outcome in iui cycles when compared to controls (without pre-washing the catheter). catheter washing is performed routinely before embryo transfer, however it is not done for iui catheters. therefore no data is available on applying the technique to iui catheters prior to insemination.

objectives: primary objective: to determine if pre-washing the catheter before insemination improves the pregnancy outcome in women undergoing iui. secondary objectives: 1. to evaluate the impact of pre-washing the catheter before insemination on the ectopic pregnancy rate in women undergoing iui. 2. to evaluate the impact of pre-washing the catheter before insemination on the miscarriage rate in women undergoing iui. 3. to evaluate the impact of pre-washing the catheter before insemination on the multiple pregnancy rates in women undergoing iui. study design: the study will be a prospective double blind trial among women undergoing iui at the muhc reproductive centre using a cluster randomized design. the week will be defined as the unit for the clusters of randomization. weeks will be allocated to one of the following groups: * group 1 = pre-washing group (patients will have the iui with a pre-washed catheter during that week) * group 2 = control group (no pre-washing before iui during that week) a random block size will be used to minimize the risk of non-blinding. the study is double-blind, neither the patients nor the physicians performing iui will know whether the catheter was washed or not, as both the sample and the catheter will be prepared by the andrology lab technician. the cluster randomization design is justified since the management of the unit will not allow us to perform a randomization at the patient level. however a very low intra-correlation coefficient (icc) between patients is expected.

Eligibility criteria:
inclusion criteria: * infertile women age ranges from 18 to 40 years at the time of treatment at the muhc reproductive centre. * patients undergoing iui. * fresh and frozen sperm treatment cycles * hormone induced and natural cycle (no hormonal stimulation). * patients speaking english or/and french. * patients able to consent. exclusion criteria: * patients younger than 18 years or older than 40 years of age. * patients undergoing ovarian stimulation without iui. * patients who have been recruited in our study in a previous iui cycle. * patients who don't speak english or french. * patients who are not able or refuse to consent. * patient who are recruited in a different iui research study.

Keywords: intrauterine insemination insemination catheter prewashing pregnancy outcome
pain assessment following placement of a percutaneous radiologic gastrostomy and predictive factors

Conditions: Gastrostomy Complications; Gastrostomy

Summary: a 12 months mono-center, descriptive study, to evaluate pain and predictive factors following placement of percutaneous radiologic gastrostomy (prg). the primary objective is to evaluate the abdominal pain associated with percutaneous radiologic gastrostomy (prg) placement.

prg is a pathway first of all enteral nutrition that has several advantages: local anesthesia, possible in case of esophageal stenosis, rates of successful tube placement higher for radiologic gastrostomy than for percutaneous endoscopic gastrostomy (peg). abdominal pain following percutaneous radiologic gastrostomy (prg) placement is a recognized complication. however, the prevalence and degree of severity of pain are poorly characterized. this pain often requires antalgic treatment. the primary objective is to evaluate the abdominal pain from baseline until 7 days after radiologic gastrostomy (prg) placement. the secondary objective is to evaluate predictive factors

Eligibility criteria:
inclusion criteria: * needing a radiologic gastrostomy under local anesthesia * age ≥ 18 years old * read, write and understand the french language exclusion criteria: * patient under guardianship, deprived of liberty, safeguard of justice * patient presenting a serious psychiatric pathology that does not allow compliance with the completion of the questionnaires (at the discretion of the investigator) * refusal to participate in research
transcriptomic signatures in gastric adenocarcinoma

Conditions: Gastric Adenocarcinoma

Summary: gastric adenocarcinoma (gac) accounting for the major percentage of all stomach malignancies is associated with a poor overall survival of 25-30% despite the advancement in treatment strategies. several factors associated with tumor microenvironment (tme) are thought to play an important role in tumorigenesis and acquired chemoresistance to therapies that are not otherwise addressed by the comprehensive molecular classification of gac given by tcga and acrg. in the present study investigators intend to do transcriptome profiling of gac tumor tissue and adjacent normal tissue to investigate differentially expressed genes between the two in relation to tme which might help in identification of gene signatures that are clinically relevant with survival outcome in gastric adenocarcinoma.

this study on gastric adenocarcinoma is retrospective as well as prospective that will be conducted at sgpgims, lucknow, india. patients undergoing gastric resection at the department of surgical gastroenterology who are diagnosed with gac based on the endoscopic biopsy in the department of pathology will be recruited for the study. for the retrospective part of study, cases will be selected based on histological findings retrieved from hospital information system and patient records. for sample collection, surgically resected fresh specimens will be collected in rnalater and stored at -80⁰c. archived formalin fixed paraffin embedded (ffpe) tissue blocks for retrospective cases will be retrieved and reviewed histopathologically. after a confirmed diagnosis of gac, tissues will be processed to obtain tumor and normal tissue for experimental part. rna from the tumor and normal area will be extracted from ffpe blocks and fresh tissue specimens. whole transcriptomic next generation sequencing will be performed after successful quality check, library preparation and amplification. the gene expression data obtained from sequencing will be bioinformatically analyzed to elucidate differential gene expression between tumor and adjacent normal tissue in relation to tme. the significantly differentially expressed genes between the tumor and normal areas will be annotated and identified using bioinformatic packages for gene annotation. using statistical analysis, the differentially expressed genes will be correlated with the patient's clinical features and outcome to identify tme genes with significant prognostic value.

Eligibility criteria:
inclusion criteria: * patients with origin of tumor in distal part of stomach * patients who underwent total or partial gastrectomy after biopsy examination * availability of follow up in radiotherapy or gastro department * availability of ffpe gastrectomy specimen tissue of selected cases in histopathology exclusion criteria: * patients with origin of tumor in proximal part of stomach * patients with only biopsy available * patients whose follow-up is not available * unavailability of ffpe tissue blocks

Keywords: gastric cancer tumor microenvironment transcriptomics differential gene expression
augmentation of treatment-resistant depression with an analog of the neuroactive steroid allopregnanolone

Conditions: Major Depressive Disorder

Summary: major depressive disorder (mdd) is highly prevalent and nearly 70% of individuals with mdd do not respond to standard antidepressant therapies despite adequate dosing. an effective and well-tolerated antidepressant augmentation therapy would have important clinical and public health implications. neuroactive steroid hormones are known to directly activate neurotransmitter receptors in the brain, and thus are potential candidates for augmentation therapies to enhance the effect of traditional antidepressants. the investigators hypothesize that administration of an allopregnanolone analog in women with treatment-resistant depression will improve depressive symptoms.

major depressive disorder (mdd) is highly prevalent and can have profoundly negative consequences on one's health, well-being and productivity. women are twice as likely as men to experience depression during their lifetimes. in fact, it is reported that twelve million women in the u.s. each year will experience depression, and that one in eight women will experience a clinical depressive episode during their lifetimes. additionally, nearly 70% of individuals with mdd do not respond to standard antidepressant therapies despite adequate dosing. therefore, the identification of an effective and well tolerated antidepressant augmentation therapy would have important clinical and public health implications. neuroactive steroid hormones are known to directly activate neurotransmitter receptors in the brain, and thus are potential candidates for augmentation therapies to enhance the effect of traditional antidepressants. specifically, allopregnanolone, a steroid hormone derived from progesterone, is a potent positive modulator of gaba action at gaba-a receptors, which are known to have positive effects on mood symptoms. data suggest that depression, chronic stress and posttraumatic stress disorder may be associated with low central nervous system allopregnanolone levels. the investigators propose to administer an oral allopregnanolone analog to 10 postmenopausal women with treatment-resistant depression as an add-on therapy to their current treatment for a period of 8 weeks followed by a 2-week taper. the investigators hypothesize that administration of the oral allopregnanolone analog in women with treatment-resistant depression will improve depressive symptoms.

Eligibility criteria:
inclusion criteria: 1. female, age 50-75 2. postmenopausal 3. major depressive disorder 4. currently treated with ssri or snri at adequate dose exclusion criteria: 1. serious suicide or homicide risk 2. unstable medical illness 3. substance use disorder 4. psychosis 5. use of hormones (estrogens, androgens or related hormones) 6. history of hormone responsive cancer 7. receiving strong cyp3a4 inducers or inhibitors or who intend to consume grapefruit products regularly during the study 8. alanine aminotransferase (alt) or creatinine \> 3x upper limit of normal

Keywords: postmenopausal women depression